Immatics receives FDA RMAT designation for IMA203 TCR-T monotherapy

Immatics announced that its IMA203 TCR-T program has received Regenerative Medicine Advanced Therapy designation from the FDA Center for Biologics Evaluation and Research in multiple relapsed and/or refractory HLA-A*02:01-positive and PRAME-expressing cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.